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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04972968
Registration number
NCT04972968
Ethics application status
Date submitted
13/07/2021
Date registered
22/07/2021
Titles & IDs
Public title
A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154
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Scientific title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment
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Secondary ID [1]
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2021-000648-23
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Secondary ID [2]
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M20-370
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Universal Trial Number (UTN)
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Trial acronym
AIM-PMR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Polymyalgia Rheumatica
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Condition category
Condition code
Musculoskeletal
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0
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Cardiovascular
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0
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Neurological
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0
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Other neurological disorders
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Inflammatory and Immune System
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0
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ABBV-154
Treatment: Drugs - Placebo
Treatment: Drugs - Glucocorticoid
Experimental: ABBV-154 Dose A - Participants in this group will receive dose A of ABBV-154 subcutaneously (SC) every other week (eow) for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Experimental: ABBV-154 Dose B - Participants in this group will receive dose B of ABBV-154 SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Experimental: ABBV-154 Dose C - Participants in this group will receive dose C of ABBV-154 SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Placebo comparator: Placebo - Participants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Treatment: Drugs: ABBV-154
Subcutaneous Injection
Treatment: Drugs: Placebo
Subcutaneous Injection
Treatment: Drugs: Glucocorticoid
Oral Tablet
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to Flare
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Assessment method [1]
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Flare is defined as, presence of clinical signs and symptoms of PMR and requirement to increase the glucocorticoid dose per investigator.
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Timepoint [1]
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Up to Week 52
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Secondary outcome [1]
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Percentage of Participants Achieving Flare-Free State
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Assessment method [1]
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Percentage of participants achieving flare-free state.
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Timepoint [1]
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Up to Week 24
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Secondary outcome [2]
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Cumulative Glucocorticoid Dose
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Assessment method [2]
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Cumulative glucocorticoid dose.
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Timepoint [2]
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Week 24
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Secondary outcome [3]
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Change from Baseline in Glucocorticoid Dose
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Assessment method [3]
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Change from Baseline in glucocorticoid dose.
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Timepoint [3]
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Week 24
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Eligibility
Key inclusion criteria
* Clinical diagnosis of Polymyalgia Rheumatica (PMR) and fulfillment of the 2012 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) provisional classification criteria for PMR.
* Must have had at least 2 episodes of unequivocal PMR flare.
* Must be on a stable dose of prednisone.
* Must be willing to follow the protocol-defined glucocorticoid tapering regimen.
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Have been treated with a prior TNF antagonist.
* Current use of immunomodulators other than prednisone and hydroxychloroquine.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/09/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/07/2023
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Sample size
Target
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Accrual to date
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Final
181
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Emeritus Research Sydney /ID# 229166 - Botany
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Recruitment hospital [2]
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Royal Prince Alfred Hospital /ID# 244888 - Camperdown
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BJC Health /ID# 244839 - Paramatta
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Tasman Health Care /ID# 230829 - Southport
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The Queen Elizabeth Hospital /ID# 229049 - Woodville South
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Emeritus Research /ID# 229270 - Camberwell
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Austin Health /ID# 229164 - Heidelberg
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Fiona Stanley Hospital /ID# 229050 - Murdoch
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Recruitment postcode(s) [1]
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2019 - Botany
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2050 - Camperdown
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2150 - Paramatta
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4215 - Southport
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5011 - Woodville South
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3124 - Camberwell
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3084 - Heidelberg
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Recruitment postcode(s) [8]
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6150 - Murdoch
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Polymyalgia rheumatica (PMR) is an inflammatory disease causing shoulder, hip, and neck pain and stiffness, in adults aged 50 years or older. This study evaluates how safe and effective ABBV-154 is in participants with glucocorticoid-dependent PMR. Adverse events and change in disease activity will be assessed. ABBV-154 is an investigational drug being evaluated for the treatment of PMR. Participants will be randomized into 1 of 4 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 participants, of at least 50 years of age, with PMR will be enrolled in the study at approximately 95 sites worldwide. The study is compromised of a 52 week double-blind, placebo-controlled period and a follow-up visit 70 days after the last dose of the study drug. All participants will receive a glucocorticoid taper along with the assigned dose of ABBV-154 or placebo, subcutaneously (SC) every other week (eow). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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Trial website
https://clinicaltrials.gov/study/NCT04972968
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04972968